Sanofi · 12 hours ago
Sample & Lab Coordinator (Clinical) (contract)
Cambridge, MA
Contract
Hybrid
Entry, Mid Level
2+ years expSanofi is a global healthcare company focused on patient needs, and they are seeking a Sample & Lab Coordinator to manage the lifecycle of biological samples in clinical studies. The role involves laboratory coordination, ensuring compliance with regulations, and optimizing workflows while collaborating with various teams and stakeholders.
Health CareLife SciencePharmaceuticalTherapeutics
Responsibilities
Laboratory Coordination & Quality Assurance
Receive, record, store, dispose, and ship biological samples on site in compliance with GxP and internal procedures (OPEs, GOPs, SOPs) for Biomarker/Companion Diagnostics (CDx), pharmacokinetic (PK), anti-drug antibodies (ADA) samples
Perform QC checks on shipment manifests prior to LIMS import; investigate and resolve discrepancies with stakeholders
Ensure laboratory/work areas are maintained on company’s site and equipment is qualified, calibrated, and in good working order
Manage laboratory consumables and inventory; maintain accurate records of receipts and shipments in notebooks and digital systems
Contribute to continuous improvement initiatives; propose technical and organizational enhancements and participate in process optimization working groups
Coordinate among clinical teams, research and development teams, bioanalytical/PK experts, outsourcing/clinical operations, and external partners (e.g., Central Labs, clinical research organizations, assay laboratories)
Oversee Central Lab activities including shipment of biospecimens to analytical laboratories to ensure timely delivery and analyzable quality
Support audits and inspections; act as spokesperson for sample-related processes and documentation
Contribute to biospecimen governance and study readiness by maintaining LIMS and central lab portals, supporting protocol and ICF reviews, and assisting in the development and maintenance of biospecimen documentation (e.g., Sample Management Plans, central lab documents, kit contents)
Qualification
Required
Bachelor's degree in life sciences (Biology, Pharmacy, Veterinary, or related discipline) with minimum 2 years of experience in biospecimen management and/or laboratory coordination within a regulated environment (GLP, GCLP, ICH-GCP)
Working knowledge of bioanalytical methodologies and regulatory requirements for drug development
Proficiency with GxP-compliant digital solutions for data analysis and laboratory documentation
Organizational and project management skills are plus; ability to manage multiple priorities with high accuracy
Excellent communication and interpersonal skills for cross-functional collaboration
Proficient English (written and spoken); advanced proficiency in Excel
Preferred
Master's degree in life sciences (Biology, Pharmacy, Veterinary, or related discipline)
Expertise in LIMS (e.g., Watson LIMS) for study setup, sample registration, tracking, and storage
Experience with translational medicine operations (Biomarker/CDx, PK, ADA, ADC) in clinical trials
Experience with sample reconciliation between bioanalytical LIMS and clinical databases
Knowledge of CDISC standards and controlled terminology (SDTM/SEND)
Experience in preclinical study support and laboratory operations management
Company
Sanofi
Sanofi is a global biopharma company focused on prescription drugs, vaccines, and treatments for chronic, rare, and infectious diseases.
10001+ employees
H1B Sponsorship
Sanofi has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (101)
2024 (68)
2023 (59)
2022 (78)
2021 (38)
2020 (38)
Funding
Current Stage
Public CompanyTotal Funding
$6.98BKey Investors
Blackstone Life SciencesEvotec
2025-10-28Post Ipo Debt· $3B
2025-06-17Post Ipo Debt· $1.72B
2025-03-05Post Ipo Debt· $1.62B
Leadership Team
Paul Hudson
Chief Executive Officer
Francois-Xavier Roger
Chief Financial Officer
Recent News
BioWorld Financial Watch
2026-02-04
Company data provided by crunchbase